The Recall Desk
SevereFDA (Devices)·Z-2433-2023·Announced 2023-09-06

Cardiosave Hybrid IABP devices recalled for temperature and pumping function failures

Datascope is recalling Cardiosave Hybrid intra-aortic balloon pumps due to reported temperature alarms that can cause loss of pumping function or unexpected standby mode. Users have reported these system failures in critical cardiac support devices.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: FDA Class I designation for a critical intra-aortic balloon pump with reported system failures causing loss of pumping function. Although no injuries or deaths have been reported in the source, the loss of function in a life-critical cardiac device presents serious patient risk.

Plain-English summary

Datascope Corp. is recalling Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), critical devices used to provide cardiac support. The recall affects 11,574 units across multiple part numbers (0998-00-0800 series), with all lot numbers included.

Users have reported "System Over Temperature" alarms associated with loss of pumping function and/or the device entering Standby mode. These failures interrupt the device's essential cardiac support function, creating risk for patients dependent on these devices.

The affected devices have been distributed nationwide in the United States (5,413 units) and internationally (6,161 units). The FDA has classified this recall as Class I, the most serious classification for medical devices.

The recalled product

Product
Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-UC-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-UC-0800-52, 0998-00-0800-53, 0998-UC-0800-53, 0998-00-08
Manufacturer
Datascope Corp.
Category
Medical Device — Cardiac Devices / Intra-aortic Balloon Pump
Hazard
  • thermal-malfunction
  • loss-of-function

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • All Lot Numbers. Model: 0998-00-0800-31
  • UDI: 10607567109053
  • Model: 0998-UC-0800-31
  • UDI: N/A
  • Model: 0998-00-0800-32
  • UDI: 10607567111117
  • Model: 0998-00-0800-33
  • UDI: 10607567109008
  • Model: 0998-UC-0800-33
  • Model: 0998-00-0800-34
  • UDI: 10607567111940
  • Model: 0998-00-0800-35
  • UDI: 10607567109107
  • Model: 0998-00-0800-45
  • UDI: 10607567108421
  • Model: 0998-00-0800-52
  • UDI: 10607567108438
  • Model: 0998-UC-0800-52
  • Model: 0998-00-0800-53
  • UDI:10607567108391

Distribution

Distributed nationwide across the United States.

Related recalls

Same category